Regenerating cavernous tissue to reverse sexual disfunction

ABSTRACT

A treatment that regenerates cells, remodels collagen, and reverses atrophy to restore full sexual function of human genitalia.

TECHNICAL FIELD

The present subject matter relates to treating and reversing sexualdisfunction in male and female humans.

BACKGROUND

Erectile dysfunction (ED) effects 7 out of 10 men at age 50, and 9 outof 10 at age 75. The first symptoms of ED usually start with the venousleak (trouble sustaining an erection, also known as venogenic ED) andprogresses to being able to obtain a 75% erection and continue untilcomplete impotence and atrophy have set in. For many years science hastried to solve erectile dysfunction with pharmaceuticals. Whilepharmaceuticals, such as PDE5 inhibitors, may lend a temporary effect ingiving an erection, they do not address the root causes of erectiledysfunction. Many men have reported a type of resistance to these PDE5inhibitors after 2-4 years of use.

Women also have sexual disfunction due to degeneration dot theirrespective genitalia.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawing figures depict one or more implementations, by way ofexample only, not by way of limitations. In the figures, like referencenumerals refer to the same or similar elements.

Features of the various implementations disclosed will he readilyunderstood from the following detailed description, in which referenceis made to the appended drawing figures. A reference numeral is usedwith each element in the description and throughout the several views ofthe drawing. When a plurality of similar elements is present, a singlereference numeral may be assigned to like elements, with an added letterreferring to a specific element.

The various elements shown in the figures are of drawn to scale unlessotherwise indicated. The dimensions of the various elements may beenlarged or reduced in the interest of clarity. The several figuresdepict one or more implementations and are presented by way of exampleonly and should not be construed as limiting. Included in the drawingare the following figures:

FIG. 1 is a method of a REGENmax® protocol;

FIG. 2 illustrates each side of the penis shaft covering the entirecorpus cavernosum treated with a shockwave treatment;

FIG. 3 illustrates an acoustic shockwave device applied to a male penisto perform the shockwave treatment;

FIG. 4 illustrates creating a neo-collagenesis inside the cavernoustissue using the acoustic shockwave therapy; and

FIG. 5 illustrates the female genitalia that receives the REGENmax®protocol.

DETAILED DESCRIPTION

A treatment regenerates cells, remodels collagen, and reverses atrophyto restore full sexual function of human genitalia. The treatmentincludes administering hormone regenerative therapy (HRT) to thepatient, administering acoustic shockwave therapy to the genitalia togenerate new vascularity in the genitalia, administering a lasertreatment to the genitalia and administering a shot of a tissueregeneration composition to the genitalia to regenerate tissue.

The following detailed description includes systems, methods,techniques, instruction sequences, and computing machine programproducts illustrative of examples set it in the disclosure. Numerousdetails and examples are included for the purpose of providing athorough understanding of the disclosed subject matter and its relevantteachings. Those skilled in the relevant art, however, may understandhow to apply the relevant teachings without such details. Aspects of thedisclosed subject matter are not limited to the specific devices,systems, and method described because the relevant teachings can beapplied or practice in a variety of ways. The terminology andnomenclature used herein is for the purpose of describing particularaspects only and is not intended to be limiting. In general, well-knowninstruction instances, protocols, structures and techniques are notnecessarily shown in detail.

The terms “coupled” or “connected” as used herein refer to any logical,optical, physical, or electrical connection, including a link or thelike by which the electrical or magnetic signals produced or supplied byone system element are imparted to another coupled or connected systemelement. Unless described otherwise, coupled or connected elements ordevices are not necessarily directly connected to one another and may beseparated by intermediate components, elements, or communication media,one or more of which may modify, manipulate, or carry the electricalsignals. The term “on ” means directly supported by an element orindirectly supported by the element through another element that isintegrated into or supported by the element.

The term “proximal” is used to describe an item or part of an item thatis situated near, adjacent, or next to an object or person; or that iscloser relative to other parts of the item, which may be described as“distal.” For example, the end of an item nearest an object may bereferred to as the proximal end, whereas the generally opposing end maybe referred to as the distal end.

The orientations of the eyewear device, other mobile devices, associatedcomponents and any other devices incorporating a camera, an inertialmeasurement unit, or both such as shown in any of the drawings, aregiven by way of example only, for illustration and discussion purposes.In operation, the eyewear device may he oriented in any other directionsuitable to the particular application of the eyewear device; forexample, up, down, sideways, or any other orientation. Also, to theextent used herein any directional term, such as front, rear, inward,outward, toward, left, right, lateral, longitudinal, up, down, upper,lower, top, bottom, side, horizontal, vertical, and diagonal are used byway of example only, and are not limiting as to the direction ororientation of any camera or inertial measurement unit as constructed oras otherwise described herein.

Additional objects, advantages and novel features of the examples willbe set forth in part in the following description, and in part willbecome apparent to those skilled in the art upon examination of thefollowing and the accompanying drawings or may be learned by productionor operation of the examples. The objects and advantages of the presentsubject matter may be realized and attained by means of themethodologies, instrumentalities and combinations particularly pointedout in the appended claims.

Reference now is made in detail to the examples illustrated in theaccompanying drawings and discussed below.

There is a direct correlation of sustained low testosterone causing adegenerative effect to the collagen in the cavernous tissue and thesmooth muscle cells (SMC) and the tunica albuginea of the penis.Furthermore, atherosclerosis of the penile vessels that occurs withageing causes a decrease in penile oxygen tension. This correlationapplies to female genitalia as well.

The decrease in penile elasticity and compliance are explained by hechanges in the ratio of penile collagen that occur with aging. Contraryto the common view that testosterone deficiency or replacement onlyeffects sexual desire, it also causes penile atrophy. There is acorrelation between testosterone deficiency, cavernosal fibrosis, andED. This disclosure details a multi-modality protocol referred to byapplicant as REGENmax® that restores functionality and reverses penilefibrosis and atrophy. The REGENmax® protocol also restores functionalityof female genitalia.

The REGENmax® protocol is shown at 10 in FIG. 1 . This protocol isapplicable to both the male and female genitalia. A process is firstdescribed for treating the male penis, and then for treating the femaleclitoris, labium majora, and the Gräfenberg spot, commonly referred toas the G-spot and which is part of the clitoral network.

At block 12, a complete hormone and blood panel is obtained On a malepatient. Then, an appropriate dose of testosterone pellets isadministered related to the testosterone deficiency, referred to ashormone replacement therapy (HRT). In an example, patients with labresults being below 500 total testosterone are raised to between 900 and1100 through HRT.

At block 14, in the same session, the trans dermis 13 on each side ofthe penis shaft 15 covering the entire corpus cavernosum 11 as shown inFIG. 2 is treated with a shockwave treatment at the time of the bloodpanel. In an example, the shockwave treatment includes a GAINSwaveprotocol using an acoustic shockwave device 17 as shown in FIG. 3 , suchas a device available from Storz Medical AG of Switzerland. In anexample, power of the acoustic shockwave device 17 has a power settingof 3.6, at a frequency of 10 Hz. The trans dermis 13 on each side of thepenis shaft 15 covering the entire corpus cavernosum 11 is pulsed 2000times, with 1000 pulses on the dorsal side, and 500 pulses on each sideof the internal bulb of the penis 15. This treatment aides in thecreation of new vascularity, as well as micro tears in the cavernoustissue and smooth muscle cells (SMC) which yield a cellular regenerationof the tissue. The GAINSwave therapy protocol creates microtraumas inthe tissue stimulating a cascade of immune responses. This cascade ofimmune responses treats the underlying cause of erectile disfunction bystimulating nitric oxide production leading to increased blood flow tothe penis 15, breaks up microplaques in the small blood vessels of thepenis 15, stimulates angiogenesis, the development of new blood vessels,and stimulating neurogenesis the formation of new nerve tissue forimproved sensitivity.

At block 16, a laser 19 is then applied to the penis 15, such as using aSP Dynamis Pro Nd:YAG laser available from Fotono of Dallas, Texas,using a 9 mm spot size, 180 j/cm², 8 second pulse duration, and apainting technique. The practitioner pulls the penis 15 taught, thenpaints 4 minutes on each side of the external penis covering the corpuscavernosum 11. This process heats the internal tissue of the penis 15 toapproximately 60° C. creating a neo-collagenesis inside the cavernoustissue as illustrated in FIG. 4 .

At block 18, a shot of HEshot® available, from the Sexual WellnessCenter of Texas, Frisco, Texas, the Applicant of this application, isinjected into the penis 15. The HEshot® is based on Cytosomes® availablefrom Neobiosis Labratories of Gainsville, Florida. The application ofthe HEshot® to the male penis 15 according to this disclosure is a noveltreatment to treat sexual disfunction of the male genitalia. A SHEshot®,also available from the Sexual Wellness Center of Texas, is applied tothe genitalia of women as shown in FIG. 5 . In an example, the HEshot®only needs to be given one time, either at the time of the GAINSwavetherapy, or a period thereafter such as 2 weeks. In an example, theHEshot® is administered using a 1 ml syringe with a 31 g needle. 1 ml ofHEshot® is drawn and .5 ml is injected into the corpus cavernosum 11 ata 45° angle into the mid shaft on each side of the penis 15. The HEshot®is 10 times more regenerative than Platelet-rich plasma (PRP), and itworks at the molecular and cellular level to regenerate new tissue inthe genitalia.

In an example, the REGENmax® protocol 10 includes treatments thatcontinue every other week 6-8 times. At that point, a period of sixweeks is given as a regeneration time. The REGENmax® protocol 10treatments then continue for another 6-8 times every other week. Verbalevaluations are taken at each treatment. The HRT continues every 16weeks with new labs and continued pellet therapy.

STUDY

In a study, 50 males ages 49-75 were treated consistently over one yearwith the REGENmax® protocol 10. Of the 50 men, 10 were type II diabetics(controlled by medication and diet) and all 50 reporting ED for at leasta year or more. Patients 62 and younger are defined as YA (younger age)and patients 65 and older are defined as OA (older age). The severity ofED was rated using a number system 1-5, 1 being severe and 5 being mild.Of the OA patients, 2 of the 29 were rated a 1, 12 were rated 2-3, 12rated 3-4, and 3 were rated a 5. Of the 21 YA patients, 1 rated a 1, and20 rated 3-5. The ratings were based on questions, on subject ability toachieve and maintain erection sufficient for intercourse and sustain todesired orgasm. These questions were answered were by the patients priorto the treatments beginning.

After one year of treatments, 47 of the 50 patients regained enough ofan erection (80% or more) for penetration and sustainability to desiredorgasm. The YA patients achieved results after the initial 6-8treatments yet continued through the entire year. The OA patientsobtained the same results, on average, after 15 treatments. All patientsreported a firming of the penis in the flaccid state. The 3 patientsthat did not obtain desired results achieved less than a 50% of anerection, were all three diabetics and two were smokers of over a pack aday.

With respect to treating females with issues including sexualdisfunction, the REGENMax® protocol 10 using the SHEshot® isadministered to the female genitalia including the clitoris 20, thelabium majora 22, and the G-Spot 24 as shown FIG. 5 .

The REGENmax® protocol 10 is done in the same order and using the sametechniques used with men. The laser procedure is done intra-vaginallyfor all atrophy, incontinence, and vaginal tightness issues as well asextra-vaginally for labia regeneration and uses Fotona's Er:YAGwavelength laser. The GAINSwave procedure is done trans clitoral, andthe SHEshot® is injected .5 ml into the clitoris 20 and .5 ml into theG-spot 24. HRT is done on women as well.

It will be understood that the terms and expressions used herein havethe ordinary meaning as is accorded to such terms and expressions withrespect to their corresponding respective areas of inquiry and studyexcept where specific meanings have otherwise been set forth herein.Relational terms such as first and second and the like may be usedsolely to distinguish one entity or action from another withoutnecessarily requiring or implying any actual such relationship or orderbetween such entities or actions. The terms “comprises, ” “comprising,”“includes,” “including,” or any other variation thereof, are intended tocover a non-exclusive inclusion, such that a process, method, article,or apparatus that comprises or includes list of elements or steps doesnot include only those elements or steps but may include other elementsor steps not expressly listed or inherent to such process, method,article, or apparatus. An element preceded by “a” or “an” does not,without further constraints, preclude the existence of additionalidentical elements in the process, method, article, or apparatus thatcomprises the element.

Unless otherwise stated, all measurements, values, ratings, positions,magnitudes, sizes, and other specifications that are set forth in thisspecification, including in the claims that follow, are approximate, notexact. Such amounts are intended to have a reasonable range that isconsistent with the functions to which they relate and with what iscustomary in the art to which they pertain. For example, unlessexpressly stated otherwise, a parameter value or the like may vary by asmuch as 10% from the stated amount.

In addition, in the foregoing Detailed Description, various features aregrouped together in various examples for the purpose of streamlining thedisclosure. This method of disclosure is not to be interpreted asreflecting an intention that the claimed examples require more featuresthan are expressly recited in each claim. Rather, as the followingclaims reflect, the subject matter to be protected lies in less than allfeatures of any single disclosed example. Thus, the following claims arehereby incorporated into the Detailed Description, with each claimstanding on its own as a separately claimed subject matter.

While the foregoing has described what are considered to be the bestmode and other examples, it is understood that various modifications maybe made therein and that the subject matter disclosed herein may beimplemented in various forms and examples, and that they may be appliedin numerous applications, only some of which have been described herein.It is intended by the following claims to claim any and allmodifications and variations that fall within the true scope of thepresent concepts.

What is claimed is:
 1. A method of treating sexual disfunction ofgenitalia of a human patient, comprising: administering hormoneregenerative therapy (HRT) to the patient; administering accousticshockwave therapy to the genitalia to generate new vascularity in thegenitalia; administering a laser treatment to the genitalia using anneodymium-doped yttrium aluminum garnet (Nd:YAG) laser pulsed with a 8second pulse duration, 9 mm spot size, 180 J/cm², for 4 minutes on eachside of the genitalia, the laser treatment generating non-ablativethermal energy to heat internal tissue of the genitalia to 60 degreesCelsius, and remodel collagen in the genitalia without mechanicalstimulation; and administering a shot of a tissue regenerationcomposition to the genitalia to regenerate tissue.
 2. The method asspecified in claim 1, wherein the laser treatment uses a paintingtechnique.
 3. The method as specified in claim 1, wherein the shockwavetherapy generates micro tears in cavernous tissue and smooth musclecells (SMC) to yield a cellular regeneration of the tissue.
 4. Themethod as specified in claim 3, wherein a trans dermis on each side of apenis shall covering a corpus cavernosum is treated with the shockwavetherapy.
 5. The method as specified in claim 1, wherein the lasertreatment creates a neo-collagenesis inside cavernous tissue of thegenitalia.
 6. The method as specified in claim 1, wherein a dermis offemale genitalia is administered the shot.
 7. The method as specified inclaim 6, wherein a dermis of a clitoris is treated with the shockwavetherapy.
 8. The method as specified in claim 6, wherein a dermis of aGräfenberg spot is treated with the shockwave therapy.
 9. The method asspecified in claim 6, wherein a dermis of a labia majora is treated withthe shockwave therapy.
 10. A method of treating sexual disfunction of apenis of a male human patient, comprising: administering hormoneregenerative therapy (HRT) to the patient; administering accousticshockwave therapy to the penis of the patient to generate micro tears incavernous tissue and smooth muscle cells (SMC), creating cellularregeneration of the cavernous tissue and generating new vascularity inthe penis; administering a laser treatment to the penis using anneodymium-doped yttrium aluminum garnet (Nd:YAG) laser pulsed with a 8second pulse duration on each side of the penis, 9 mm spot size, 180J/cm², for 4 minutes on each side of the penis, the laser treatmentgenerating non-ablative thermal energy to heat internal tissue insidethe penis, and remodel collagen in the penis without mechanicalstimulation to create neo-collagenesis inside cavernous tissue of thepenis; and administering a tissue regeneration composition to the penisto regenerate the cavernous tissue.
 11. The method as specified in claim10, wherein a trans dermis on each side of the penis covering a corpuscavernosum is treated with the shockwave therapy.